The present invention relates, in general, to devices and methods for stopping an undesirable flow of fluid between two contiguous tissue samples, such as bleeding from a blood vessel after removal of a medical device, catheter system, or the like. More particularly, the present invention concerns a novel clotting device which includes means for depositing a clotting agent at a wound or aperture between two contiguous tissue areas, such as the opening in a blood vessel or the like following removal of a medical device or instrument therefrom. The present invention also concerns a novel method for using such a clotting device.
Many medical procedures, including both therapeutic and diagnostic procedures, require access between two contiguous tissue samples, such as through the skin and into the vascular system of the patient. For example, although various means may be used to obtain access into a vein or artery, typically access is obtained by inserting a cannula or catheter (called an introducer catheter or sheath) through the skin and into the selected blood vessel. A medical or diagnostic instrument, such as a guide wire, guiding catheter, balloon angioplasty device, atherectomy device, or the like is then inserted into the vascular system through the introducer catheter.
Depending on the procedure, to permit the insertion of the diagnostic or therapeutic device therethrough, the introducer sheath must be of relatively large diameter. This, of course, results in a relatively large hole or aperture in the vessel wall. After the medical procedure is completed, however, this aperture must be closed, and bleeding from the blood vessel stopped.
A common technique to stop such bleeding, as in cardiac balloon angioplasty procedures, is for a nurse or technician to apply continuous pressure on the aperture in the blood vessel until the blood Within the aperture clots. This may require an hour or more of medical personnel time. Unfortunately, When this procedure is utilized, there is a significant chance that upon movement by the patient, the aperture will reopen and begin bleeding again, resulting in a hematoma or other complications. Because of the risk of a hematoma, patients are usually required to remain overnight in the hospital for rest and observation, thus greatly increasing the cost of the overall procedure.
One prior device for stopping bleeding from an aperture in a blood vessel is a type of expandable plug. The plug is pushed through the opening into the blood vessel and into the blood stream. Once in the blood stream, it expands. The expanded plug is then pulled back against the aperture where, because of its expanded size, it plugs the opening. Such a device may work satisfactorily, but requires inserting and leaving a foreign object in the vessel. It is usually medically preferable to avoid inserting and leaving objects in a vessel.
Accordingly, it is a general object of the present invention to provide a clotting device, as well as a method for using such device, which are particularly useful in clotting vascular wounds resulting from insertion of a medical device, and which do not suffer from the drawbacks described above.